Half-life in non-human primates (NHP) of more than 30 days, over three times longer than bimekizumab and expected to support a dose interval of two to three times per year
Equivalent potency to bimekizumab with similar binding affinity and epitope demonstrated in several preclinical assays
First subject dosed with ORKA-002 expected in Q3 2025
MENLO PARK, CA, USA I March 07, 2025 I Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a clinical-stage biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis, today announced new preclinical data on ORKA-002, a novel extended half-life monoclonal antibody targeting IL-17A/F, from its presentation at the 2025 American Academy of Dermatology (AAD) Annual Meeting.
- ORKA-002 has an NHP half-life of more than 30 days following subcutaneous and intravenous administration, over three times longer than bimekizumab. Projections of ORKA-002 pharmacokinetics (PK) in humans indicate that a human half-life of approximately 50 days could enable dosing once every four months, while a human half-life of approximately 75 days could enable twice-yearly dosing. The NHP half-life observed for ORKA-002 supports the potential to achieve these extended dosing intervals given that other YTE-modified antibodies have had an approximately two to four times longer half-life in humans than in NHPs.
- ORKA-002 binds to a similar epitope with similar affinity to bimekizumab and shows equivalent potency across a variety of in vitro assays. ORKA-002 binds IL-17A and IL-17F with a comparable picomolar affinity as bimekizumab. Based on cryo-EM structural analysis, ORKA-002 binds to a nearly identical epitope to bimekizumab on both IL-17A and IL-17F. When assessed across multiple different assays in cell lines and primary cells, ORKA-002 also had comparable functional potency for IL-17A and IL-17F antagonism. These findings further derisk the development path for ORKA-002.
“We are highly encouraged by the exceptional properties of ORKA-002, including a half-life in NHPs that is, for the second time in two programs, one of the longest seen to date for any antibody,” said Lawrence Klein, Oruka’s Chief Executive Officer. “Bimekizumab has had a remarkable launch, showing the excitement around IL-17A/F inhibition. We believe ORKA-002 could offer an even better product profile to people with psoriasis, psoriatic arthritis, and additional indications.”
About ORKA-002
ORKA-002 is a novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-17A/F. Dual inhibition of both IL-17A and IL-17F has shown superior efficacy compared to IL-17A inhibition alone in psoriasis (PsO) and other indications, as shown by the performance of Bimzelx (bimekizumab) compared to Cosentyx (secukinumab) and Taltz (ixekizumab) in Phase 3 trials. These therapies all utilize monthly maintenance dosing in PsO and psoriatic arthritis (PsA), except Bimzelx in PsO patients weighing <120 kg, where Q8W maintenance dosing is recommended. In contrast, ORKA-002 has the potential to be dosed just two to three times a year in PsO and PsA, which we believe could allow ORKA-002 to become the leading therapy in the IL-17 class. Data from studies in non-human primates and other preclinical assays show that ORKA-002 binds to a similar epitope with similar affinity as bimekizumab and has a significantly extended half-life over three times longer than bimekizumab.
About Oruka Therapeutics
Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice a year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com and follow Oruka on LinkedIn.
SOURCE: Oruka Therapeutics
Post Views: 1,210
Half-life in non-human primates (NHP) of more than 30 days, over three times longer than bimekizumab and expected to support a dose interval of two to three times per year
Equivalent potency to bimekizumab with similar binding affinity and epitope demonstrated in several preclinical assays
First subject dosed with ORKA-002 expected in Q3 2025
MENLO PARK, CA, USA I March 07, 2025 I Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a clinical-stage biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis, today announced new preclinical data on ORKA-002, a novel extended half-life monoclonal antibody targeting IL-17A/F, from its presentation at the 2025 American Academy of Dermatology (AAD) Annual Meeting.
- ORKA-002 has an NHP half-life of more than 30 days following subcutaneous and intravenous administration, over three times longer than bimekizumab. Projections of ORKA-002 pharmacokinetics (PK) in humans indicate that a human half-life of approximately 50 days could enable dosing once every four months, while a human half-life of approximately 75 days could enable twice-yearly dosing. The NHP half-life observed for ORKA-002 supports the potential to achieve these extended dosing intervals given that other YTE-modified antibodies have had an approximately two to four times longer half-life in humans than in NHPs.
- ORKA-002 binds to a similar epitope with similar affinity to bimekizumab and shows equivalent potency across a variety of in vitro assays. ORKA-002 binds IL-17A and IL-17F with a comparable picomolar affinity as bimekizumab. Based on cryo-EM structural analysis, ORKA-002 binds to a nearly identical epitope to bimekizumab on both IL-17A and IL-17F. When assessed across multiple different assays in cell lines and primary cells, ORKA-002 also had comparable functional potency for IL-17A and IL-17F antagonism. These findings further derisk the development path for ORKA-002.
“We are highly encouraged by the exceptional properties of ORKA-002, including a half-life in NHPs that is, for the second time in two programs, one of the longest seen to date for any antibody,” said Lawrence Klein, Oruka’s Chief Executive Officer. “Bimekizumab has had a remarkable launch, showing the excitement around IL-17A/F inhibition. We believe ORKA-002 could offer an even better product profile to people with psoriasis, psoriatic arthritis, and additional indications.”
About ORKA-002
ORKA-002 is a novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-17A/F. Dual inhibition of both IL-17A and IL-17F has shown superior efficacy compared to IL-17A inhibition alone in psoriasis (PsO) and other indications, as shown by the performance of Bimzelx (bimekizumab) compared to Cosentyx (secukinumab) and Taltz (ixekizumab) in Phase 3 trials. These therapies all utilize monthly maintenance dosing in PsO and psoriatic arthritis (PsA), except Bimzelx in PsO patients weighing <120 kg, where Q8W maintenance dosing is recommended. In contrast, ORKA-002 has the potential to be dosed just two to three times a year in PsO and PsA, which we believe could allow ORKA-002 to become the leading therapy in the IL-17 class. Data from studies in non-human primates and other preclinical assays show that ORKA-002 binds to a similar epitope with similar affinity as bimekizumab and has a significantly extended half-life over three times longer than bimekizumab.
About Oruka Therapeutics
Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice a year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com and follow Oruka on LinkedIn.
SOURCE: Oruka Therapeutics
Post Views: 1,210
